YHLO received its first IVDR, paving the way for EU IVD market

In this October, YHLO proudly announced that it has received its first IVDR Certificate from BSI, one of the most reputable notified bodies under the In Vitro Diagnostics Regulation (IVDR). The certificate covers Anti-TPO—a Thyroid Peroxidase Antibody Assay Test Kit, PCT—A Procalcitonin Assay Test Kit and etc., which are applied to Chemiluminescence Immunoassay platform.

Manufacturers of in-vitro diagnostic instruments and regents are required to obtain certifications and display CE mark in principle after 26 May 2022 in order to enter the EU market. These certifications confirm that the products meet the IVDR’s high quality standards, which focus on protecting the health of patients and users. Compared to IVDD, IVDR has a risk classification of IVD devices, tightened requirements for post-market surveillance and vigilance, and tightened requirements for clinical evidence and conformity assessment.

In order to supply reliable products and services to customers, YHLO team has been working hard to obtain the CE mark in accordance with the IVDR. With the mission of “Focus on healthcare, better life with technology”, YHLO will continue to provide reliable, high-quality healthcare innovations and services worldwide to improve human well-being.

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YHLO Joined Hands With Peking University In Molecular Diagnosis

One more YHLO - Beckman Coulter joint automation system installed

YHLO Joined Hands With Peking University In Molecular Diagnosis

One more YHLO - Beckman Coulter joint automation system installed